AJ13--Research Support - Prototype of Cardiovascular Valve Leaflet Cutter System. Intent to Sole Source to Resolution Medical

The Veteran s Administration (VA) Office of Research and Development, Regional Procurement Office East in Pittsburgh, PA intends to negotiate on a sole source basis with Resolution Medical based in Minneapolis, MN on behalf of the VA San Francisco Healthcare System.

The requirement is to continue designing and developing a Leaflet Cutter System. This will be a follow-on to contract 36C24E23P0138 which set the prototype and potential to continue.

The current Leaflet Cutter System received funding to conduct prototyping activities which will ultimately benefit veteran patients if the concept becomes a product. The project consists of creating a functional catheter-based cardiovascular valve leaflet cutter which includes the capability to retain or retrieve the valve tissue. The catheter works in concert with a catheter-based temporary valve. A successful prototype will be used in bench studies to generate proof of concept results in support of future funding to develop the product further.

Two Leaflet Cutter and Temporary Valve system prototypes are to be created and shall include the following:

18-20 Fr delivery system built onto steerable catheter

Can cut and retrieve leaflets from native valve or bioprosthetic valve

Mitral and aortic

Capable of functional testing in benchtop water bath and/or in vitro left heart model, ideally pulse duplicator

Sterilizable

Biocompatible materials

Materials and design meet applicable regulatory standards

Delivery date before September 30, 2025

As these devices are custom built prototype, the vendor will not provide maintenance support.

The requirement will take place at a VA facility in San Francisco, CA. The sole source is pursuant to FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This notice of intent is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation to the contracting office no later than Wednesday, Sept 11, 2024, (10:00 AM, EST). Interest/capability statements may be sent to Michael Haydo at Michael.haydo@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.